Home Applications 085941 Application 085941
Type ANDA
Sponsor CHARTWELL RX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A085941-001 PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A085941-001 PHENDIMETRAZINE TARTRATE 35MG TABLET / ORAL 1983-06-27 cb3db0bc1861…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 17 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE Calvin Scott & Co., Inc. f5c30a88-5814-5b42-e053-2995a90a437a 2026-05-21 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE Bryant Ranch Prepack 75f6c4bc-ed72-498a-822c-ecc2a13df958 2026-04-01 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE A-S Medication Solutions ef4cfd54-7d3e-4571-ae77-38ab2fd1af3d 2026-01-29 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE Acertis Pharmaceuticals, LLC 162140d3-b833-4633-9759-95821a46a690 2025-12-19 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE Virtus Pharmaceuticals, LLC cc9a0cd2-6fb9-47ab-8e39-146d2fa361c2 2025-12-19 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE Preferred Pharmaceuticals Inc. 767b5386-1e56-4eeb-8d59-510b940ab75e 2025-09-08 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE NuCare Pharmaceuticals, Inc. 342bc2a2-2751-b51a-e063-6394a90a4c43 2025-05-02 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE A-S Medication Solutions f1d265e1-522e-4a62-afda-29477fb94b8d 2025-04-04 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE Bryant Ranch Prepack 137e5fcd-9536-4fb9-9885-5dfd1127c35a 2025-01-30 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE PD-Rx Pharmaceuticals, Inc. 467ae7d7-e342-423b-be89-5d38c1abf3c9 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE KVK-TECH, INC 07bf3488-09e7-436f-af3f-94c35a7be025 2024-12-06 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE NuCare Pharmaceuticals,Inc. 05bb0569-4eed-2139-e063-6394a90acb6c 2024-09-27 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE NuCare Pharmaceuticals, Inc, 40e5b0bf-347e-30f6-e054-00144ff88e88 2024-08-14 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE Bryant Ranch Prepack 1c2370fd-6b40-48dc-a42d-2488041d5b37 2024-08-08 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate PHENDIMETRAZINE TARTRATE A-S Medication Solutions 7adaf128-fef4-4bbf-8b4a-875fe46bf68a 2023-07-18 Warnings, Adverse reactions Name fallback brand name: Phendimetrazine Tartrate generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE Bryant Ranch Prepack 8593421c-d1fb-409d-a5bb-3369da18fd2c 2023-07-12 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE Elite Laboratories, Inc 42ecacde-6859-47c6-ba44-13fb4f3b5448 2019-02-07 Warnings, Adverse reactions Name fallback brand name: PHENDIMETRAZINE TARTRATE generic name: PHENDIMETRAZINE TARTRATE